An RCT to determine the effect of a heel elevation device in pressure ulcer prevention post-hip fracture

Abstract

A randomised controlled trial set out to determine whether there are differences between complete offloading and standard care in terms of the number of new pressure ulcers (PUs) developing on the heels of older patients with fractured hips and the number or severity of new PUs on other areas of their bodies. Patients aged over 65 years in a fracture trauma unit with fractured hips were randomly allocated to receive heel elevation (DM Systems, Evanston, Illinois) plus pressure-redistributing support surface or standard care (pressure-redistributing support surface alone). Exclusion criteria included existing heel damage. Patients were assessed on pre- and postoperative days for the occurrence of new pressure damage. Patients completed a satisfaction questionnaire at discharge. 119 patients were recruited into the control group and 120 into the intervention group. Independent t-tests and chi-squared analysis showed both groups were comparable at baseline. Thirty-one subjects (26%) in the control group developed PUs compared with eight in the intervention group (7%, p<0.001). No subjects in the intervention group developed a PU on their ankles, feet or heels, whereas 29 subjects in the control group did (p<0.001). Kaplan-Meier survival curves indicated that subjects in the control group were more likely than those in the intervention group to suffer pressure damage at all time points (p=0.001). A sensitivity analysis showed that when subjects lost to follow-up were assigned the worse outcome (PU positive) those in the intervention group were still less likely to develop PUs than the control group (p=0.001). The offloading device was rated as comfortable overall by 59% of subjects. The findings suggest that offloading reduces the incidence of heel ulcers.